iGlarLixi (previously called LixiLan) is a once daily, single injection of the investigational fixed-ratio combination of Lantus® (insulin glargine injection) 100 Units/mL and Lyxumia® (lixisenatide) (GLP-1 receptor agonist) for the treatment of adults withtype 2 diabetes.

The pivotal Phase III clinical trials – LixiLan-O and LixiLan-L were performed to check the safety and efficacy profile of the combination therapy. LixiLan-O was a 30 weeks trial in 1,170 patients with T2D patients. iGlarLixi showed significantly higher reductions in HbA1c compared to Lantus® or Lyxumia® alone. Similarly, 736 patients with T2D in LixiLan-L also showed significantly greater reductions in HbA1c after 30 weeks when compared to insulin glargine 100 Units/mL. The results were unveiled at a meeting of the American Diabetes Association.

Sanofi’s Lantus® is a long-acting synthetic analog of human insulin which fetches about 84.3% revenue for the company from the diabetes field whereas Lyxumia® which is a once-daily GLP receptor agonist for diabetes treatment was invented by a Danish pharma- Zealand Pharma A/S and later Sanofi licensed its global development and commercialization rights from Zealand.

The results of both the clinical trials have been included in the regulatory filings to the US FDA and European Medicines Agency (EMA) and the decision of FDA is anticipated in August 2016 and EMA decision may arrive in the first quarter of 2017.

If the drug gets approved, it would have to compete with two Novo Nordisk’s drug. One is Tresiba which is FDA approved long-acting, basal insulin to control blood sugar in adultdiabetes mellitus patients. The other one is a combination therapy, Xultophy which is approved in the European Union for T2D.

According to the forecasts of Thomson ReutersCortellis, LixiLan sales would reach about $1 billion in 2020.

“These studies reflect Sanofi’s commitment to innovative approaches in developing medicines intended to help patients meet their needs throughout their diabetes journey,” said Jorge Insuasty MD, Senior Vice President, Global Head of Development, Sanofi. “We look forward to continuing to work with the FDA and EMA as they complete their reviews and to receiving their decisions“.

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